Statistical Programmer

This is a fully remote position, open to applicants in India.

📋 Description

• Create tailored programming code using SAS or alternative software to produce summary tables, data listings, graphs, and derived datasets.

• Ensure that outputs align with quality standards and meet project specifications.

• Conduct validation programming and address discrepancies with programmers, biostatisticians, and project team members.

• Keep project teams updated on programming progress and any issues encountered.

• Adhere to relevant SOPs, work instructions, and regulatory guidelines such as ICH.

• Maintain comprehensive and up-to-date project documentation, testing, and quality-control records.

• Manage timelines and priorities across multiple simultaneous projects.

• Create specifications for datasets and outputs based on statistical or sponsor requirements.

• Facilitate productive internal meetings and track action items effectively.

• Ensure timely delivery of concurrent programming outputs while providing risk mitigation strategies.

• Act as the lead statistical programmer and oversee other programming staff.

• Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.

• Engage in sponsor, kickoff, and bid defense meetings.

• Mentor programming staff through training, work reviews, and constructive feedback.

• Serve as a technical authority on clinical drug development, industry standards, and electronic submissions.

• Establish SOPs, guidelines, policies, and procedures in collaboration with biostatistics and statistical programming teams.

• Create programming tools and macros to enhance standardization and efficiency.

• Offer guidance and training on CDISC Standards.

• Conduct compliance reviews of CDISC deliverables, including SDTM, ADaM, and DEFINE.XML.

• Participate in industry standards organizations and communicate changes to upcoming standards.

• Transfer deliverables as needed.

• Perform other assigned job-related duties.

⛳️ Requirements

• Bachelor's degree, ideally in a scientific or statistical field; an equivalent combination of education and proven programming experience may be accepted in lieu of the degree.

• Significant programming experience in SAS or other necessary software, preferably within a clinical trial setting.

• Capability to lead multiple complex and/or global projects with teams of statistical programmers.

• Familiarity and experience with CDISC Standards for regulatory agency requirements.

• Experience with submissions to regulatory agencies is preferred.

• Background in mentoring others in clinical trial processes and CDISC Standards.

• Exceptional written and verbal communication skills.

• Proficiency in reading, writing, speaking, and understanding English.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Technical and therapeutic area training provided.

• Recognition from peers.

• Total rewards program.

• Inclusive workplace culture.

• Minimal travel may be required.